Dose-Response Effect Exercise and Depression

Depression Clinical Trial

Official title:

Dose-Response Effect of Exercise on Depression and Brain-Derived Neurotrophic Factor (BDNF) in Sedentary Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166095
• Other study ID #: STUDY00005112
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: University of Central Florida
• Contact: Amoy Fraser, PhD, CCRP, PMP
• Phone: 4072668742
• Email: amoy.fraser[@]ucf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study aims to address gaps in the literature by evaluating the objectively measured dose-response relationship between exercise and depression symptoms; examining changes in resting (Brain-derived Neurotrophic Factor) BDNF from baseline to week 10 of an exercise intervention; and assessing varying exercise intensities on enjoyment, affect, and health-related quality of life in sedentary young adult college students.

Description:

This 10-week randomized single-blind controlled trial will consist of an exercise intervention and attention control condition. A two-week familiarity trial period will be followed by 8 weeks of structured exercise. Objectively measured physical activity will be remotely monitored via Fitbit to examine its effect on depressive symptoms in sedentary young adult college students.

Approximately 48 enrolled college students ages 18 - 25 will be recruited for the proposed study and randomized with a 1:1:1 allocation to one of the following conditions:

1. high-dose (HD) moderate to vigorous physical activity (MVPA) (n=16)

2. moderate-dose (MD moderate to vigorous physical activity (MVPA) (n=16)

3. a walking (W) attention control (n=16)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• enrolled UCF college students aged 18 to 25

• mild to moderate depressive symptoms

• willing to wear a Fitbit for extended periods of time during the study

• willing to participate in moderate-to-vigorous PA

• physically able to participate in exercise safely

Exclusion Criteria:

• under 110 lbs

• history of bad reaction to a past blood draw

• have been advised by a medical provider to not give/donate blood

• presence of anemia

• current cognitive therapy or antidepressant medication

• diagnosis of a co-occurring condition such as attention deficit hyperactivity disorder (ADHD)

• diagnosis of a serious mental illness (SMI) such as schizophrenia or bipolar disorder

• pregnant or nursing

• current smoker

• beta-blocker medications

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• high-dose
Participants will be asked to perform a high-dose (HD) (i.e., 300 minutes of MVPA per week) of structured exercise for 10 weeks. Exercise modality and schedule will be participant- selected and may consist of any combination of aerobic and strength training that elevates the heart rate between 64 - 95 percent of estimated heart rate max
• Walking attention control
The attention control group will be asked to wear the Fitbit activity tracker to monitor their sleep each night for 10 weeks.
• moderate-dose
Participants will be asked to perform a moderate-dose (MD) (i.e., 150 minutes of MVPA per week) of structured exercise for 10 weeks. Exercise modality and schedule will be participant- selected and may consist of any combination of aerobic and strength training that elevates the heart rate between 64 - 95 percent of estimated heart rate max

Locations

Country	Name	City	State
United States	University of Central Florida	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Central Florida	American College of Sports Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain-derived Neurotrophic Factor (BDNF) assay	A fasted (> 8 hours) blood draw will be performed at baseline and post-treatment to measure resting serum BDNF levels. Serum concentrations of total BDNF will be measured with Human BDNF Human ELISA assay kits for total serum BDNF from ThermoFisher Scientific	1 year
Secondary	Fitbit for heart rate	Heart rate (bpm.) will be collected through Fitabase from the Fitbit as the participants exercise and/ or walk.	1 year
Secondary	Fitbit for physical activity data	Duration of weekly physical activity (min.) data will be collected from the Fitbit activity trackers.	1 year